Hello,


Please share resume for this position.



*Job Title*

Trackwise- Business Support Admin

*Relevant Experience*

*(in Yrs)*

8-10

*Technical/Functional Skills*



-Knowledge and experience with the administration of TrackWise).
- Familiarity with database management system
- Strong understanding of the current pharmaceutical industry and
applicable regulations.
- Strong knowledge of 21 CFR Part and Annex 11 Regulations
- Strong knowledge of applicable Quality Systems and current Good
Manufacturing Practice (cGMP) requirements (FDA, EU, ICH)
with the ability to assess compliance risks.
- Experience in implementing and maintaining GXP computer systems in a
validated state.

*Roles & Responsibilities*

This individual will perform the role of a Business Administrator in the
Corporate Quality department for the TrackWise Application.
- Performs daily business administrative tasks related to functional
support (Level 2 Support) and general user account administration of the
TrackWise

- Drive the analysis, development, testing, and deployment of
configuration, workflow, reporting and/or software updates to improve the
overall accuracy, efficiency, and effectiveness of the system
- Effectively identifies and resolves system issues and appropriately
communicates gating items to management, Business Process Owner Leads and
users
- Conducts impact assessment of GXP computer systems related deviations and
change controls.
- Assist in end user training on TrackWise application as needed
- Participates in the improvement and development of Quality Systems to
ensure quality and adherence to cGMPs.
- Works on problems of greater complexity in scope where analysis of
situations or data requires in-depth evaluation of various
factors, good judgment is required in resolving problems and making routine
recommendations.
- Exercises judgment within approved policies and procedures in selecting
methods, techniques and evaluation criteria for
obtaining results.
-- Supports the development and management of quality metrics to optimize
performance, productivity, effective resource
planning, and management review.
- Participates in cross-functional project teams.

   -

*Duration of assignment *(in Months)

One year







*Thanks & Regards,*

*Dipika Kamboj*

*United Software Group Inc.. *

*565 Metro Place South. Suite # 110 *

*Dublin, OH 43017 *

*[email protected]* <[email protected]>

*www.usgrpinc.com* <http://www.usgrpinc.com/>

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